A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance

Not Applicable

Not yet recruiting

• Conditions: Mid Face Volume Deficit

• Registration Number: NCT07186595
• Lead Sponsor: AbbVie

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-09-23
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:

  • Minimal, moderate, or severe on Allergan Temple Hollowing Scale (ATHS)
  • Moderate or severe for both eyes on Allergan Infraorbital Hollow Scale (AIHS)
  • Moderate or severe on Allergan Cheek Smoothness Scale (ACSS)
  • Moderate, significant, or severe on Mid-face Volume Deficit Scale (MFVDS)
  • Moderate or severe on Nasolabial Fold Severity Scale (NLFSS)
  • Minimal, mild, or moderate on Allergan Lip Fullness Scale 2 (ALFS2)
  • Moderate or severe on Allergan Chin Retrusion Scale (ACRS)
  • Moderate or severe on Allergan Loss of Jawline Definition Scale (ALJDS)

• Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.

Exclusion Criteria

• Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening.
• Excessively loose skin in the face and/or neck.
• Tendency to develop hypertrophic scarring and/or keloid scarring.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q™ Satisfaction with Facial Appearance Scale	Month 3	The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face.
Number of Participants with Adverse Events (AEs)	Up to approximately Month 6	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving "Responder" Status of Global Aesthetic Improvement on Facial Appearance Based on the Principal Investigator's Assessment Using the Global Aesthetic Improvement Scale (GAIS)	Month 3	The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area.
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale	Month 3	The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale	Month 3	The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Feels Scale	Month 3	The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin feels.
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Looks Scale	Month 3	The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin looks.
Percentage of Participants Achieving "Responder" Status Based on Participant Responses on the Natural Look Satisfaction Scale (NLSS) Assessment	Month 3	The NLSS is an 8-item scale that measures satisfaction with various attributes that are associated with natural looking results following aesthetic treatment.